FDA Study Confirms Baby Formula Sold in US Safe for Consumption

Federal health officials announced Wednesday that comprehensive testing confirms baby formula sold throughout the United States meets safety standards for infant consumption.

The Food and Drug Administration examined over 300 samples from 16 different manufacturers distributed across the country, according to their latest report.

Investigators looked for dangerous substances including heavy metals like arsenic, cadmium, lead and mercury, along with pesticides, synthetic chemicals, and phthalates.

Most samples showed either no detectable contamination or extremely minimal levels, federal officials reported.

Health Secretary Robert F. Kennedy Jr. has been working to minimize chemicals in food products and initiated a comprehensive review of infant formula nutrition standards last year. Earlier this year, federal health authorities documented 28 confirmed cases of infant botulism connected to ByHeart formula through February — marking the first global outbreak of this type linked to baby formula, according to the FDA.

Although contamination levels remained low overall, certain samples required additional examination, the FDA noted. Regulators examined powdered formulas, ready-to-use liquids and concentrated liquid products.

Test results showed mercury was absent in 95% of samples, lead was undetectable in 20% of samples, 99% showed no measurable pesticides and most PFAS chemicals were not found.

Officials also examined a limited number of breast milk samples, discovering that most contained at least one measurable contaminant, while 15% showed no contamination.

Trace amounts of contaminants may occur naturally in food products, including baby formula and breast milk, or may enter through environmental contact during manufacturing processes.

Federal health agencies launched Operation Stork Speed last year, a program designed to verify the quality, safety and nutritional standards of domestically produced infant formula.

The FDA announced it will maintain ongoing testing and release findings from additional surveys, while Secretary Kennedy plans to conduct a roundtable discussion with industry leaders in May.

“Producing infant formula at scale in the U.S. is a matter of national security, and these results affirm the safety of our domestic supply,” Abbott, maker of Similac, said on Wednesday, adding its U.S. formulas meet heavy metal limits set by the EPA, the European Commission and Health Canada.